This invention relates to connectors for use with intravenous administration lines and systems in the medical field, and more particularly relates to a two part IV quick-connect/disconnect safety assembly that makes it more convenient to attach and detach a patient to and from an IV system.
Intravenous therapy has a long history of use in supplying patients with medicament, nourishment or fluids. One of the problems associated with intravenous therapy of ambulatory patients is that the patient cannot be easily disconnected from and reconnected to an intravenous administration line for short periods of time. To safely and easily disconnect the patient for even a short period of time requires the assistance of skilled medical personnel. The ambulatory patient is often required to be attached to the intravenous system and must wheel a stand holding the IV liquid supply wherever the patient goes. Being restricted in this manner can cause the patient to forgo activities of short duration that would be beneficial to the patient.
It is often necessary for hospital staff to move patients from location to location within the hospital in order to perform tests and certain medical treatments. It is not necessary or desirable to have the patient hooked up to the intravenous system during some of these activities. Removing a patient from an intravenous system and re-establishing the patient on the system takes a substantial amount of time even for a medical professional skilled in the techniques of intravenous therapy. With hospital costs rising dramatically there is considerable advantage in a connector device that allows the medical staff to be able to quickly and safely connect and disconnect a patient from an intravenous therapy administration line while expending a minimum amount of time in doing so.
The prior art has addressed some of the above stated problems. For example, U.S. Pat. No. 4,511,359 issued to Vaillancourt describes a three-part sterile dialysis connection device for home use. The three parts are a male connector which terminates in a catheter tube; a female connector with a hollow needle secured in place and terminating in a flexible tubing; and a molded septum assembly. Vaillancourt places the molded septum assembly in the receiver end of the female connector. The female connector is then slid over the male connector, thereby pushing the septum assembly into place between the male and female connectors, and into friction fit with the male connector, and also causing the sharpened needle in the female connector to pierce the molded septum assembly. The hollow needle provides a path for fluid flow between the two connector parts. When the male and female connectors are separated, the needle is removed from the self-sealing septum, and the septum assembly remains with and covering the male connector because of its friction fit therewith.
Another three-part home dialysis connection device is described in U.S. Pat. No. 4,810,241 issued to Rogers which provides a sterile connection by mechanical and chemical means. The three parts include two connectors, one attached to an influent tube and the other to the catheter tube, and a cylindrical shaped tube in which there is highly absorbent material saturated with antiseptic. The two connectors in turn connect one to each end of the cylinder. As the end connectors are introduced into the central cylinder connector, they are sterilized by the antiseptic in the cylinder and remain in antiseptic contact during the entire time they are being used for dialysis. A sterile environment is maintained on the catheter tubing side of the IV system only for so long as the catheter side tubing is in the connector cylinder. Care must be taken not to let the disinfectant in the cylinder dry out or evaporate.
A somewhat different solution to the problem was taken by U.S. Pat. No. 4,559,043 issued to Whitehouse, et al. which provides a four-piece assembly including a distal connector, a proximate connector, a septum fitting between and held in place by the distal and proximate connectors, and an adapter with a through bore able to accept a hollow needle, the adapter being used in conjunction with the proximate connector. A hollow needle attached to a standard luer extension T which connects to the adapter is pushed through the adapter needle bore and pierces the septum which is held between the proximate and distal connectors, thereby establishing fluid flow. When the hollow needle attached to the luer T is removed, the septum is sealed, but the needle is exposed, presenting a needlestick hazard.
The prior art of FIG. 1 shows a connector 100 manufactured by ICU Medical Inc., Irvine, Calif. and illustrates the extreme complexity some IV line connectors have embodied in an attempt to solve the problems in the art. The prior art connector 100 has a female portion 110 and a male portion 103. A spring loaded thumb lever 112 which protrudes from the side of the female connector 110 is provided to clamp a rear flange 124 of the male connector 103 against the end surface 117 of the female connector 110. The plastic spring 109 shown in FIG. 1 provides the spring action which holds the lever 112 in the locked position The connector is complex and difficult to manufacture, expensive to make, and potentially hazardous due to the high probability of the lever 112 becoming caught on bed rails, medical equipment, or tubing at a patient's bedside.
While the devices of the prior art may be effective for their particular purposes, the requirement for a simple, low-cost, quick-connect/disconnect safety assembly is not filled. The prior art does not show a device which has all of the virtues in a single device of being simple and inexpensive to manufacture, providing standard means such as luer fittings for attachment to other devices, and providing means for shielding the needle after use to prevent accidental needlesticks.